None listed
Conditions
Brief summary
The DREAM study aims to compare a single dose of temazepam to a placebo, to investigate whether this will improve sleep in patients in the intensive care unit (ICU) of a tertiary hospital. Currently, there is no evidence on whether temazepam, a commonly prescribed sleep aid in the ICU, is effective in promoting sleep for critically ill patients. Patients will be given a weight adjusted dose of temazepam, or a blinded placebo, on a single night during their stay in the ICU. Both subjective measures of sleep (bedside nurse assessment), and objective measures (polysomnography) where available will be collected.
Interventions
A single dose of Temazepam, administered enterally by the bedside nurse.
Dose administration will be as follows:
For patients aged over 80 years and/or weigh under or equal to 50 kg (actual body weight), 10 mg of temazepam will be administered.
For patients aged less than or equal to 80 years and weighing less than or equal to 100 kg, 20 mg of temazepam will be administered.
For patients aged less than or equal to 80 years and weighing greater than 100 kg, 30 mg of temazepam will be admini
A single dose of Temazepam, administered enterally by the bedside nurse. Dose administration will be as follows: For patients aged over 80 years and/or weigh under or equal to 50 kg (actual body weight), 10 mg of temazepam will be administered. For patients aged less than or equal to 80 years and weighing less than or equal to 100 kg, 20 mg of temazepam will be administered. For patients aged less than or equal to 80 years and weighing greater than 100 kg, 30 mg of temazepam will be administered. Adherence to the intervention will be monitored by asking the bedside nurse to place the used syringe in a container provided on the day of the study. Research staff will then check for the empty syringe and fill out the drug reconciliation log accordingly.
Sponsors
Melbourne Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Aged >/= 18 years • The treating clinician considers it highly likely that they would prescribe a pharmacological sleep aid that evening
Exclusion criteria
• The treating clinician believes that an alternative sedating drug (e.g. quetiapine, melatonin, etc.) is in the best interest of the patient, • They are pregnant, • They have a known hypersensitivity to temazepam, and • Were previously enrolled in this trial.
Outcome results
None listed